Papaverine Phentolamine Injection (Vital Care) – Sterility Risk (2022)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN INJ 150MG/5MG/10MCG/VIAL SOLUTION, 5 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Brand
Pharmacy Plus, Inc. dba Vital Care Compounder
Lot Codes / Batch Numbers
Lot: 65976, BUD: 10/27/2022
Products Sold
Lot: 65976, BUD: 10/27/2022
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN INJ 150MG/5MG/10MCG/VIAL SOLUTION, 5 ML vial, Rx only, Vital C due to Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the produc. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, LA, MS, TN
Page updated: Jan 7, 2026